Tests lumateperone for depression in older adults with treatment-resistant depression
Compares lumateperone with a placebo sugar pill in adults aged 60 and older with depression.
Plain-language title generated from the registry record
Registry title: Lumateperone for Late-Life Depression
Key facts
- Where
- St Louis and Tucson, United StatesSee the 2 sites
- Phase
- Phase 3
Where in United States
- Washington University School of MedicineSt Louis, United StatesTaking people
- University of ArizonaTucson, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eric Lenze
- Trial code
- NCT07623135
- Record updated
- 16 September 2026
- Original description
The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).Read full original descriptionShow less
Lumateperone for Late-Life Depression
The purpose of this research study is to examine how well a medication called lumateperone (Caplyta) works to relieve depression in older adults with treatment-resistant depression. Lumateperone (Caplyta) is approved by the U.S. Food and Drug Administration to treat Major Depressive Disorder in adults who are also taking another antidepressant medication. This study will compare lumateperone (Caplyta) to placebo (a sugar pill without medication).
Inclusion: Age >=60; Current unipolar non-psychotic major depression determined by SCID-5; MADRS score >=20 at screening and >=18 at baseline; Treatment-resistance defined as documented history of non-response to at least two oral medications of adequate dose and duration in this episode or previous episode, OR clinician determination that treatment augmentation is appropriate; Currently taking oral antidepressant prescribed at least minimum therapeutic dose and for at least six weeks duration; MMSE score of >/=24.
Exclusion: Dementia; High risk for suicide, defined as a 4 or 5 on C-SSRS (indicating active suicidal ideation with current or recent intent or plan), and unable to be managed safely in the clinical trial. Urgent psychiatric referral will be made in these cases; High risk alcohol use: defined as a score of 6 or more on the AUDIT-C; Medically inappropriate for participation as determined by PIs.